NCT00400933

Brief Summary

The aim of this project is to analyze the impact of a psycho-educational group program on the family members and close friends of persons with eating disorders and co-morbid personality disorders.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2006

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 17, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

February 13, 2012

Status Verified

February 1, 2012

Enrollment Period

2.1 years

First QC Date

November 16, 2006

Last Update Submit

February 9, 2012

Conditions

Eating DisordersPersonality Disorders

Keywords

Psycho-educationEating disordersPersonality disordersRelatives and close friendsCaregiver burden

Outcome Measures

Primary Outcomes (1)

  • Scores on perceived caregiver burden (Experience of Caregiving Inventory [ECI])

    1 year

Secondary Outcomes (1)

  • Scores on general health and relational variables

    1 year

Study Arms (1)

psycho-education

EXPERIMENTAL

six session psycho-educational group program for family members and close friends of persons with eating disorders and co-morbid personality disorders

Behavioral: psycho-education

Interventions

psycho-educationBEHAVIORAL

six session psycho-educational group program for family members and close friends of persons with eating disorders and co-morbid personality disorders

psycho-education

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Relatives and close friends to persons receiving treatment for their eating disorder and comorbid personality disorder.
  • \> 18 years,
  • Speak and understand norwegian language, and
  • Informed consent to participate for both relative and patient.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Østmarka Psychiatric Department, St Olavs Hospital, University Hospital of Trondheim

Trondheim, Trondheim, 7044, Norway

Location

MeSH Terms

Conditions

Feeding and Eating DisordersPersonality DisordersCaregiver Burden

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Are Holen, PhD MD

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2006

First Posted

November 17, 2006

Study Start

November 1, 2006

Primary Completion

December 1, 2008

Study Completion

December 1, 2009

Last Updated

February 13, 2012

Record last verified: 2012-02

Locations

NO(1)